Abstract
Medical devices are the tool, machine, apparatus, instrument, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, treatment or prevention of an illness. Demand for medical devices around the world has drawn the attention of government agencies to make sure the effectiveness and safety of these products. The United States and European Union have established regulatory systems for medical devices, which have been constantly modified to adapt to changing security requirements. Medical devices regulation has become a most important regulatory initiative in the United States and European Union. It needs to ensure that medical devices are of high quality, obviously due to nature. In the present paper, the regulatory approval process in the United States and the European Medical Union is reviewed, with the medical device classification, competent authorities, standards, regulations, quality management systems, labeling requirements, time required for approval, post-marketing surveillance and medical device vigilance system, top 20 medical devices companies in 2016 and 2017.
Keywords: Medical Devices, Medical Devices regulation in United States, Medical Devices regulation in European Union, Global Harmonization Task Force (GHTF), regulatory approval, post-marketing surveillance.
Graphical Abstract
79
4
1
2